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FDAnews Device Daily Bulletin
Oct. 16, 2012 | Vol. 9 No. 203
EC Proposes Risk-Based Classification System for IVD Medical Devices
A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could place new requirements on the majority of current Class A IVDs by bumping them up to Class B. The new classification scheme would divide IVDs into four risk classes: A (lowest overall risk), B (moderate individual/low public health risk), C (high individual/moderate public health risk) and D (high overall risk).
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